ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE

K090554 · Boston Scientific Corp · DQX · Jul 2, 2009 · Cardiovascular

Device Facts

• Record ID: K090554
• Device Name: ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
• Applicant: Boston Scientific Corp
• Product Code: DQX · Cardiovascular
• Decision Date: Jul 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

Boston Scientific ACUITY Strait-Trak and ACUITY Mailman Venous Guidewires are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature.

Device Story

ACUITY Strait-Trak and ACUITY Mailman are hydrophilic-coated, steerable venous guidewires (182.2 cm length) with shapeable distal tips. Used by clinicians to facilitate placement of Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature. Devices provide delivery support and lead compatibility during lead placement procedures. Performance is verified through bench testing of tip flexibility, delivery support, and lead compatibility.

Clinical Evidence

Bench testing only. Testing evaluated tip flexibility, device delivery support, lead compatibility, and guidewire usage to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Hydrophilic-coated, steerable guidewires; 182.2 cm length; shapeable distal tip; radiopaque tip. Design and manufacturing processes are substantially equivalent to the Boston Scientific ChoICE PTCA guidewire family.

Indications for Use

Indicated for facilitating the placement of Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature in patients requiring such leads.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Boston Scientific ChoICE Extra Support and Mailman PTCA Guidewires (K964551)
• Guidant HI-TORQUE Whisper View Guidewire (K061453)

Submission Summary (Full Text)

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176

40554

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ACUITY Strait-Trak™ and ACUITY™ Mailman™ Venous Guidewires

### 510(k) Summar per 21 CFR §807.92

#### -2 2009 JUL

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 | | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------|
| Contact Name<br>and Information | Stacey A. Strand<br>Regulatory Affairs Specialist II<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | | |
| Date Prepared | February 26, 2009 | | |
| Proprietary<br>Name(s) | ACUITY Strait-Trak™ and ACUITY™ Mailman™<br>venous Guidewires | | |
| Common Name | Guide Wire | | |
| Product Code | DQX | | |
| Classification of<br>Device | Catheter Guidewire<br>Class II, 21 CFR Part 870.1330 | | |
| Predicate<br>Devices | Boston Scientific<br>CholCE<br>Extra Support and<br>Mailman PTCA<br>Guidewires | K964551 | May 21, 1997 |
| | Guidant<br>HI-TORQUE<br>Whisper View<br>Guidewire | K061453 | June 22, 2006 |
| Device<br>Description | Boston Scientific ACUITY Strait-Trak and ACUITY Mailman<br>venous Guidewires for Left Ventricular Lead Delivery.<br>These two Boston Scientific Guidewires are hydrophilic<br>coated steerable guidewires available in a 182.2 cm length.<br>The distal tip is shapeable. For product specifications,<br>including wire diameter, length, tip style and radiopaque tip<br>length, please refer to the product label. | | |

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Traditional 510(k) Notification ACUITY Strait-Trak™ and ACUITY™ Mailman™ Venous Guidewires 2082

Indication for Boston Scientific ACUITY Strait-Trak and ACUITY Mailman Use venous quidewires are intended to facilitate the placement of Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature. Comparison of The ACUITY Strait-Trak and ACUITY Mailman venous Technological quidewires incorporate a substantially equivalent design, Characteristics packaging, fundamental technology, manufacturing, and sterilization as those featured in the predicate Boston Scientific ChoICE PTCA quidewire family. Support of Bench testing was performed to support a determination of Substantial substantial equivalence (i.e. tip flexibility, device delivery Equivalence support, lead compatibility, and guidewire usage) to the predicate BSC CholCE quidewires. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were identified during device testing. The Indication for Use for the ACUITY Strait-Trak and ACUITY Mailman venous quidewires is substantially equivalent to the Guidant HI-TORQUE Whisper View Guidewire Indications for Use statement. Conclusion Based on the Indications for Use. technological characteristics, safety and performance testing, the ACUITY Strait-Trak and ACUITY Mailman venous quidewires have been shown to be appropriate for their intended use and are considered to be substantially equivalent to the Boston Scientific ChoICE PTCA guidewire family (K964551; cleared May 21, 1997).

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL - 2 2009

Boston Scientific Corporation c/o Ms. Stacey A. Strand Regulatory Affairs Specialist II One Scimed Place Maple Grove, MN 55311

Re: K090554

ACUITY Mailman and ACUITY Strait-Trak Venous Guidewires Regulation Number: 21 CFR 870. 1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: June 2, 2009 Received: June 3, 2009

### Dear Ms. Strand:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Stacey A. Strand

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

M. A. Willever

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) Notification ACUITY Strait-Trak™ and ACUITY™ Mailman™ Venous Guidewires

# Indications for Use

510(k) Number (if known):

K090554

Device Name: ACUITY Strait-Trak™ and ACUITY™ Mailman™ venous Guidewires

Indications for Use:

Boston Scientific ACUITY Strait-Trak and ACUITY Mailman Venous Guidewires are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature,

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. A. Willeboerner

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Ko90554

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